Today, Theravance Biopharma (TBPH) published top-line results from a Phase 3, randomized, double-blind, placebo-controlled multicenter Phase 3 study assessing the safety and efficacy of ampreloxetine compared to placebo for treating symptomatic neurogenic orthostatic hypotension (nOH). Afterward, the Theravance Biopharma stock gradually sank and overall lost 11% in two days. At the moment of writing, the price is open at $8.04. The study has not yet reached its primary endpoint. Most of the treatment-related side effects were mild or moderate, and severe side effects occurred in two patients receiving placebo and four patients receiving ampreloxetine. None of them was considered related to the study drug; there were no reports of fatal outcomes.
Study 0169 (NCT03750552) was a randomized, double-blind, placebo-controlled, parallel-group study of phase 3, 4 weeks to evaluate the efficacy and safety of ampreloxetine compared with placebo in patients with symptomatic nosology (n=195). Patients from study 0169 were eligible to participate in Study 0170, a multicenter randomized phase 3 trial lasting 22 weeks, to assess the persistent benefit in the efficacy and safety of ampreloxetin in patients with symptomatic nosology. The company plans to present the results at a future scientific forum.
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